Pelvic floor symptoms in women and men; towards an integrated sex- and gender-specific approach to diagnosis, treatment and referral

Pelvic floor symptoms (PFS) are prevalent and often bothersome. They include micturition problems (e.g. urinary incontinence), defecation problems (e.g. fecal incontinence), pelvic organ prolapse, sexual problems (e.g. erectile dysfunction) and genito-pelvic pain. These symptoms may substantially impair quality of life. As research on PFS is predominantly performed among women, the male pelvic floor is a relative ‘terra incognita’. The pelvic floor is an anatomical and functional unit, and therefore different PFS may co-occur. Although this would strongly call for an integrated approach to PFS, currently PFS are treated by different specialists in secondary care (e.g. gynecologist, urologist, colorectal surgeon, sexologist). This leads to many successive diagnostic tests, suboptimal treatments, high patient burden, and substantial medical costs. Integrated care is offered in Pelvic Care Centers, especially for complex cases with interacting health problems. Primary care would be an ideal setting for an integrated approach early in the course of symptom development in order to prevent complexity and chronicity of PFS. For this setting, evidence on PFS is scarce. To contribute to an integrated sex- and gender-specific approach to PFS in primary care, we need evidence on clinically relevant clusters of PFS, on factors that are associated with the development of PFS and with the course of PFS, and on healthcare seeking behavior, among both women and men. Evidence on clusters of symptoms is needed as different PFS frequently co-occur, and as patients with a single PFS may need a different type of treatment than patients with several symptoms. Knowledge of factors that are associated with the development or course of (clusters) of PFS among women and men may contribute to gender-specific prevention, diagnosis and treatment of PFS. Information on gender differences in factors that reveal the impact of PFS on daily life may help to set priorities in the treatment of patients with PFS. Finally, knowledge on gender differences in healthcare seeking behavior, including barriers and facilitators of health care seeking, patient preferences and satisfaction may contribute to more patient-centered care. We will use a mixed-methods approach, combining quantitative and qualitative study designs. We will set up a sustainable prospective cohort including at least 2,500 adult women and 2,500 adult men (18 years and older), with and without PFS. We will invite eligible participants through general practices. Participants who consent to participate will fill out validated online questionnaires at baseline and after 12 and 24 months. Baseline characteristics will include questions on, among others, sex, gender identity, gender role, sexual orientation, ethnicity, education, and work. We will assess the presence of PFS by questionnaires that have been validated among women or men. We will measure lower urinary tract symptoms, sexual functioning, prolapse symptoms, anorectal symptoms, genito-pelvic pain. Furthermore, anxiety and depression, trauma, quality of life, self-esteem, characteristics of pregnancy, delivery and menopause, and social and economic participation will be assessed. To minimize withdrawal of participants with low literacy, the online questionnaire will have audio and video support. Patients who do not have access to the internet can use a laptop of the research team; in case filling out an online questionnaire is too difficult the questionnaire can be completed during an interview. For participants who consent, we will also analyze their medical general practice records to supplement the self-administered questionnaires and to explore sex and gender differences in diagnosis, prognosis and treatment of PFS. Time scale for medical record review is 3 years prior to baseline measurement up to the end of follow up (2 years). A representative sample of women and men will be invited for a physical examination to assess pelvic floor disorders and muscle function. Furthermore, a subsample of patients will be invited for a qualitative study consisting of semi-structured face-to-face interviews on healthcare seeking behavior, including barriers and facilitators, preferences and satisfaction. Our scoping review will provide an overview of studies on sex and gender differences in diagnosis, prognosis, and treatment of PFS between women and men, and of (inter)national clinical practice guidelines that contain information on a gender-specific approach of PFS. Finally, we will organize multidisciplinary expert-panel meetings to examine the implications of the evidence gathered in this research project for present clinical practice guidelines of PFS. The prospective cohort described in this project will offer unique opportunities for future studies among sub-samples - e.g. on gender differences in the effectiveness of treatments or on the accuracy of diagnostic tests - and may serve as the basis for long-term follow-up of PFS.